Best Practices

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Some cleanrooms are reopened after a shutdown. Reasons for the shutdown could be worst case events such as bad weather conditions, power outage, maintenance schedule or human errors. When the cleanroom is reopened, it is essential to verify that the room meets the expected standards. Failure to restore the cleanroom to acceptable conditions may result in rejections during inspections.

Unexpected things happen everywhere. Cleanrooms are no exceptions for such. Worst-case events like bad weather conditions, power outage, airflow suspension, or serious excursions during environmental monitoring (EM) can occur. They are unavoidable and might require a temporary major or minor shutdown of the cleanroom.

Post the implementation of GDUFA, in the current year 4 cohort of FY 2016, there has been a very significant positive change with respect to ANDA review timelines. The initial screening deficiencies/ information requests or acceptance letters are generally being issued within 1 month of filing ANDAs. The most important screening deficiency/information request issued by USFDA is related to eCTD aspects, which in general is given least importance. RA professionals generally ensure to meet the requirements of ANDA Filing Checklist, which doesn’t summarize the eCTD requirements in detail, but gives a link to USFDA website where we get all the guidelines and eCTD requirements details.

Current Good Manufacturing Practices are regulations published by FDA to provide criteria for complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act). cGMP requires all drug products that are developed and produced are safe, properly identified, of the correct quality, strength, and purity. The word “current” is used in conjunction with GMP as technologies are constantly evolving and so do the requirements to attain GMP compliance. Even though cGMP regulations have been in place since long time, the large number of 483's and warning letters demonstrate that companies have problems with implementation. The GMP regulations are codified in 21 CFR 210-211.

The news these days is filled with reports of one company or the other being fined for corporate misbehavior – evidence of a lack of governance, risk and compliance or GRC programs in these organizations. A number of regulatory agency citations in fact do highlight weak internal controls and failure of management and board to set the tone in terms of ethical conduct. It is not justenough to have a GRC program in place, however. Companies must ensure that it is in line with current regulatory requirements and takes into account the challenging nature of doing international business in volatile conditions. In order to make a GRC program effective,companies must carry out periodic audits of the program’s processes. This white paper explains what makes a GRC program effective and the five best practices that companies should follow to successfully audit their GRC programs.

In recent years, cosmetics companies have been increasingly pulled up by the FDA for failing to follow regulations, especially those governing manufacturing and branding of products.Companies big and large have been sent Warning Letters for making scientifically unproven claims, adulterating their products, microbial contamination at manufacturing facilities and more.This White Paper puts together five best practices that can help cosmetics manufacturers address these issues and others in order to avoid regulatory enforcement actions and worse.

The explosion in use of social media over the past few years has been both a blessing and a curse for life sciences companies and consumers who use their products. While platforms such as Facebook and Twitter might present a great opportunity for marketing products, the limitations of the tools can present regulatory pitfalls for companies and dangers to consumers. The rapid pace of technological progress has caught agencies such as the FDA and FTC on the wrong foot and they have struggled to formulate and implement regulations on social media use. It is clear though that the onus for compliance lies with regulated companies. However, the overlap between regulations for conventional marketing and promotion and social media guidelines that are still evolving has led to confusion about compliance requirements. This white paper discusses 5 ways in which drug and device companies can stay on the right side of the regulatory agencies and ensure that they don’t attract penalties for violations.

When the FDA inspector calls, even the most experienced professional can lose confidence and make the inspection process more painful and confrontational than it needs to be. Firms are very often unsure of how to deal with the FDA inspector’s requests and can complicate matters by becoming too antagonistic or go in the opposite direction and volunteer more information than necessary. This white paper discusses different types of FDA inspections and the seven best practices that FDA regulated companies can follow in order to ensure a trouble-free FDA inspection process that reduces the risk of multiple and unnecessary Form 483 observations.

A recent study showed that US consumers spent USD 23 billion on OTC drugs in 2010. The huge market for these drugs spurs companies to create and launch more products. The market growth has, however, also forced the FDA to crack the whip on regulatory violations. While a number of manufacturers of OTC drugs are warned for CGMP violations, many also face enforcement action for shoddy labeling and branding. Considering that consumer trust is vital for the sales of an OTC drug, news that a manufacturer has been fined or warned for mislabeling can lead to a significant drop in consumer confidence, affecting the company bottom line. This White Paper explains six best practices that manufacturers can follow to ensure that they comply with the FDA’s stringent OTC drug and drug-cosmetic labeling regulations.

Drug Enforcement Administration (DEA) audits are primarily carried out to ensure that there is no diversion or misuse of controlled substances.The audits also help to educate registrants in case of any identified discrepancies.This white paper addresses compliance issues relating to DEA audits, provides assistance to registrants to ensure strict compliance and the right adoption of drug ordering practices. It also details the correct ways to interact with inspectors during a DEA audit.

Compliance with the principles of GLP (Good Laboratory Practices) is a legal requirement for test facilities. After each GLP study is completed or terminated, a GLP final report must be prepared for submission to the regulatory agency. Test facilities should follow GLP guidelines and good archival practices as non-compliance compromises the quality and integrity of the study and gives scope for rejections,warning letters and citations by the FDA. This white paper primarily intends to provide information about necessary documentation, requirements for GLP final reports, and also details about best practices to be followed in final reporting and archiving for regulatory compliance.

The dietary supplement market has witnessed huge growth in the last decade and this boom in sales been accompanied by increased regulatory scrutiny. Both the government and federal agencies are concerned about the dangers posed to public health by misleading claims and labels on these products. The FDA is cracking down on the health claims being put forward by dietary supplement makers about their products. The agency is planning to widen its surveillance of the market to detect such claims.This white paper details how dietary supplements are currently regulated and six labeling best practices that dietary supplement manufacturer should follow in order to ensure compliance.

21 CFR Part 11 specifies requirements for handling electronic records and electronic signatures and applies to any records covered by FDA regulations that exist in an electronic form. The main objective behind implementing this regulation was to prevent fraud while facilitating, promoting the possible use of electronic technology to reduce expenditures incurred from paper sources.This white paper provides an overview of FDA requirements for electronic systems and the applicability of 21 CFR Part 11. It also details consequences for non-compliance and six key aspects FDA regulated firms should focus on so as to ensure compliance.

Avoid FDA warning letters for combination product non-compliance by adopting current best practices Confusion still exists among manufacturers as to what regulations cover research and development and marketing as well as FDA approval of combination products. The agency has only recently finalized its Current Good Manufacturing Practices (CGMP) for combination products. This white paper explains the current regulatory environment relating to combination products and five best practices manufacturers should follow in order to achieve FDA compliance and approval.

The FDA has been cracking down on non-compliance in vitro diagnostic products or IVDs recently. Manufacturers have not been adhering to the strict regulations governing the use of these products, and have been falling short when it comes to the compliant labeling of these devices. This White Paper puts together five best practices that can help IVD manufacturers improve their compliance with labeling and avoid FDA citations, Warning Letters, product recalls and worse.

The FDA has strengthened its scrutiny of animal drug products as public awareness of the issues surrounding their use and adverse events have increased. A number of manufacturers have been warned about marketing products with treatment claims without first obtaining approval from the agency. The approval process for a veterinary drug is as complicated and rigorously analyzed by the FDA as the one for human medicines. This White Paper details what is considered an animal drug, the different types of applications and finally explains five best practices that manufacturers can adopt in order to ensure better compliance with the application process for a new animal drug.

On May 3, 2012, the FDA released new guidance on ‘Sterility Testing of Biological Products’ after revising the existing requirements for licensed biological products. The new rule on sterility eliminated specific requirements for most products and aims to establish a system in which manufacturers can adopt product-specific and appropriate testing procedures.

This article discusses the potential implications and requirements of the regulation.

GlaxoSmithKline, the British drug maker agreed to pay $3 Billion in fines for promoting its best-selling drugs for unapproved uses and failing to report safety data. The company also faces criminal charges and civic penalties for improper marketing of a half-dozen other drugs and for violating the government's Medicaid program. The fraud settlement includes $1bn in criminal fines and $2bn in civil fines.

This article explains 11 important questions arising from the fraud settlement by GSK.

Annual Product Review (APR) - Product Quality Review (PQR) reports are the first documents reviewed by health authorities while inspecting a manufacturing facility. The importance of this report is such that even a small error in reported data may have severe impact on product quality and patient safety. Considering its criticality and importance, organizations must try to eliminate errors through process standardization and automation.

This White Paper by Aman Gupta explains six steps that can lead to successful execution of APR-PQR process automation, helping eliminate regulatory reporting errors.

About the Author:

Aman Gupta is an experienced business process consultant. He has worked in several industries including Pharma to help clients in streamlining their processes for productivity gains. He is a CPIM & CSCP (Certified in Production and Inventory Management & Certified Supply Chain Professional), having good command on process areas like demand management, regulatory compliance, online campaign management, supply chain and software package implementation. He can be reached at aman.gupta@wipro.com.

The FDA’s latest rule on New Dietary Ingredient Notification has created confusion on when, who and how the submissions are to be done to the agency. This article details some of the most important issues addressed in the new rule.